Zdrowie i gospodarka · 16/02/2006

Guidance for Industry on Reports on the Status of Postmarketing Study Commitments-Implementation of Section 130 of the Food and Drug Administration Modernization Act of 1997; Availability

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled "Reports on the Status of Postmarketing Study Commitments--Implementation of Section 130 of the Food and Drug Administration Modernization Act of 1997." This guidance provides recommendations on procedures, content, and format for submitting a postmarketing study status report for an approved human drug or licensed biological product; timeframes for FDA's review of postmarketing study commitments; and information about postmarketing study commitments that will be available to the public. The guidance is intended to assist applicants in meeting the requirements of section 130 of the Food and Drug Administration Modernization Act of 1997.